Study of Premenstrual Syndrome and Premenstrual Dysphoria

The relevance of changes in ovarian steroids in the pathophysiology of menstrually-regulated
mood disorders (MRMD [the term Premenstrual Dysphoria (PMD) will be employed in the text
instead of MRMD] remains to be fully characterized. The purpose of this protocol is to allow
for the careful screening of patients and healthy volunteers for participation in research
protocols that examine the role of gonadal steroids in PMD and for the collection of natural
history data. Women in this protocol will undergo an evaluation which may include: a
psychiatric interview; a diagnostic interview; daily symptom rating scales; a medical
history; a physical exam; blood and urine laboratory evaluation; and a request for medical
records. The data collected may also be linked with data from other PMD protocols (e.g., DNA,
psychophysiology tests, treatment studies, etc.) for the purposes of better understanding the
diagnosis, pathophysiology, and treatment response of women with PMD. Upon conclusion of the
evaluation process, subjects will either be offered participation in a research protocol and
will sign the appropriate informed consent, or will be considered not appropriate for
participation in research and will be referred back into the community.

Finally, we wish to identify a group of women with recurrent brief depression, who will serve
as an additional control group for the patients with menstrual cycle-related mood disorders.
This protocol, then, serves as a screening and evaluation protocol to recruit subjects who
are characterized with standard measures in this protocol and then offered participation in
related studies.

- INCLUSION CRITERIA:

The subjects of this study will be women who meet the following criteria:

- history within the last two years of at least six months with menstrually-related mood
or behavioral disturbances of at least moderate severity - that is, disturbances that
are distinct in appearance and associated with a notable degree of subjective
distress;

- a 30% increase in mean negative mood ratings (relative to the range of the scale
employed) in the premenstrual week compared with the week following the end of menses
in at least two of three cycles;

- age 18 to 50;

- not pregnant and in good medical health;

- regular menses.

Subjects who do not meet the criteria listed above but who do meet diagnostic criteria for
recurrent brief depression will also be studied. The criteria for recurrent brief
depression include the following:

- dysphoric mood or loss of interest or pleasure;

- duration less than two weeks;

- four of the following symptoms: poor appetite or significant weight loss (when not
dieting) or increased appetite or significant weight gain; insomnia or hypersomnia;
psychomotor agitation or retardation; loss of interest or pleasure in usual
activities, or decrease in sexual drive; loss of energy; fatigue; feelings of
worthlessness, self-reproach, or excessive or inappropriate guilt; diminished ability
to think or concentrate, slowed thinking, or indecisiveness;

- impairment in usual occupational activities;

- at least one-two episodes per month over one year.

Age-matched women without mood and behavioral disorders will be recruited.

EXCLUSION CRITERIA:

Subjects should have no general medical illness that is primary (i.e., appears to be
causing the mood disorder);

Current alcohol or substance use or dependence (excluding nicotine) of sufficient magnitude
to require independent, concurrent treatment intervention (e.g., antabuse or opiate
treatment, but not including self-help groups).